FDA UDI
In Commercial Distribution
🇺🇸 United States
PC
DI: 00026072025338
·
Model: 55-01-0028
·
Allied Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PC
- Primary DI
- 00026072025338
- Version / Model
- 55-01-0028
- Company Name
- Allied Medical, LLC
- Labeler DUNS
- 119066872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-11
- Public Version
- 3
- Public Version Date
- 2025-10-13
- Public Version Status
- Update
- Public Device Record Key
- fd63aae9-4d94-4ca8-a4a7-4a9360e5af63
Device Description
CARBOLIME,GECOMPACTSTYLE,10/CS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBL | Absorbent, Carbon-Dioxide | Anesthesiology | 868.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36051 | Carbon dioxide absorbent | An absorbent material (e.g., granules of treated soda lime) intended to be placed into a reusable carbon dioxide absorber to remove carbon dioxide (CO2) from the exhaled gases in a patient breathing circuit by chemical reaction. It is typically available in large plastic containers [e.g., 5 kilogrammes (Kg) by weight] and poured into clean, reusable absorbers. The absorbent is typically manufactured to change colour during its use (e.g., from white to violet, pink to white, or green to violet) to indicate need for replacement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40026072025336 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00026072025338 | GS1 |